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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL NBB
Change History For

Serious Adverse Events

2,171 Shared Subjects

Clinical Trials: Serious Adverse Events
Clinical Assessments
Adverse Events
05/08/2014
sae01
05/08/2014
View Data Structure
01
Definition
Submission Template
Element Name Change Description Before Now When
interview_age VALUE_RANGE, VALUE_RANGE: 0 :: 1260 VALUE_RANGE: 0::1440 04/04/2024 13:54 PM
q53_b1a NOTES, NOTES: Required field NOTES: MM/DD/YYYY Required field 12/21/2023 16:07 PM
height_met NOTES, NOTES: 999 = Missing NOTES: 999 = Missing; -999 = No Data 07/05/2023 13:17 PM
weight_met NOTES, NOTES: 999 = Missing NOTES: 999 = Missing; -999 = No Data 07/05/2023 13:17 PM
medication9_name ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 500 05/24/2023 10:47 AM
medication8_name ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 500 05/24/2023 10:47 AM
medication7_name ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 500 05/24/2023 10:47 AM
medication4_name ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 500 05/24/2023 10:47 AM
medication3_name ELEMENT_SIZE, ELEMENT_SIZE: 150 ELEMENT_SIZE: 500 05/24/2023 10:46 AM
medication2_name ELEMENT_SIZE, ELEMENT_SIZE: 200 ELEMENT_SIZE: 500 05/24/2023 10:46 AM
medication12_name ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 500 05/24/2023 10:45 AM
medication11_name ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 500 05/24/2023 10:45 AM
race VALUE_RANGE, VALUE_RANGE: American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported; Other Non-White; Other; Prefer not to answer VALUE_RANGE: American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported; Other Non-White; Other 04/06/2023 12:02 PM
race VALUE_RANGE, VALUE_RANGE: American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported; Other Non-White; Other VALUE_RANGE: American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported; Other Non-White; Other; Prefer not to answer 04/06/2023 11:39 AM
race VALUE_RANGE, VALUE_RANGE: American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported; Other Non-White VALUE_RANGE: American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported; Other Non-White; Other 07/15/2022 10:00 AM
aescode NOTES, NOTES: NOTES: 999= Missing Data 03/25/2022 13:57 PM
race VALUE_RANGE, VALUE_RANGE: American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported VALUE_RANGE: American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported; Other Non-White 07/29/2021 12:53 PM
height_met NOTES, NOTES: NOTES: 999 = Missing 07/12/2021 15:47 PM
weight_met NOTES, NOTES: NOTES: 999 = Missing 07/12/2021 15:47 PM
weight_std NOTES, NOTES: -1 = Not known NOTES: -1 = Not known; 999 = Missing 07/12/2021 15:47 PM
sex DESCRIPTION DESCRIPTION: Sex of the subject DESCRIPTION: Sex of subject at birth 07/09/2021 10:38 AM
study DESCRIPTION DESCRIPTION: Study DESCRIPTION: Study; The code for each individual study 01/11/2021 08:51 AM
interview_date NOTES, NOTES: Required field NOTES: 01/08/2021 10:21 AM
vis_type NOTES, NOTES: 1=Phone; 0=doctor's office; 2=No, not phone interview NOTES: 1=Phone/remote; 0=doctor's office/In person; 2=No, not phone interview 09/15/2020 14:48 PM
saeothsp ELEMENT_SIZE, ELEMENT_SIZE: 250 ELEMENT_SIZE: 600 06/25/2020 15:06 PM
description_of_sae ELEMENT_SIZE, ELEMENT_SIZE: 300 ELEMENT_SIZE: 800 06/25/2020 15:06 PM
visit ELEMENT_SIZE, ELEMENT_SIZE: 50 ELEMENT_SIZE: 60 06/25/2020 10:25 AM
version_form ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 121 03/25/2020 12:57 PM
sex VALUE_RANGE, , NOTES, VALUE_RANGE: M;F NOTES: M = Male; F = Female VALUE_RANGE: M;F; O; NR NOTES: M = Male; F = Female; O=Other; NR = Not reported 02/21/2020 13:02 PM
update NOTES, NOTES: 1=Updated NOTES: 1= yes; 0= no 01/08/2020 19:28 PM
other DESCRIPTION DESCRIPTION: Other:: DESCRIPTION: Other prevent dose increase 10/18/2019 13:19 PM
medication10_dose ELEMENT_SIZE, ELEMENT_SIZE: 50 ELEMENT_SIZE: 100 09/16/2019 12:01 PM
gender PERMANENTLY ALIASED gender sex 04/22/2019 00:00 AM
medication6_name ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 500 02/28/2019 18:42 PM
medication5_name ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 500 02/28/2019 18:42 PM
medication1_name ELEMENT_SIZE, ELEMENT_SIZE: 150 ELEMENT_SIZE: 500 02/28/2019 18:42 PM
site ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 101 01/30/2019 17:56 PM
dthdate TYPE, ELEMENT_SIZE, TYPE: Date ELEMENT_SIZE: TYPE: String ELEMENT_SIZE: 30 01/15/2019 13:17 PM
medication1_name ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 150 09/13/2018 12:26 PM
gender DESCRIPTION DESCRIPTION: Sex of the subject DESCRIPTION: Sex of the subject 08/22/2018 10:43 AM
gender DESCRIPTION DESCRIPTION: Block Brief 2000: Sex of the subject DESCRIPTION: Sex of the subject 08/20/2018 10:21 AM
gender DESCRIPTION DESCRIPTION: Sex of the subject DESCRIPTION: Block Brief 2000: Sex of the subject 08/14/2018 16:18 PM
visit NOTES, NOTES: Character description of each type of visit NOTES: 07/18/2018 13:11 PM
ae_serious_signific VALUE_RANGE, , NOTES, VALUE_RANGE: NOTES: VALUE_RANGE: 0;1 NOTES: 0 = No; 1 = Yes 05/02/2018 17:31 PM
medication1_name NOTES, NOTES: 999= Legitimately skipped; NOTES: 0 = No medication; 999= Legitimately skipped 02/27/2018 17:14 PM
medication2_name NOTES, NOTES: 999= Legitimately skipped; NOTES: 0 = No medication; 999= Legitimately skipped 02/27/2018 17:14 PM
medication3_name NOTES, NOTES: 999= Legitimately skipped; NOTES: 0 = No medication; 999= Legitimately skipped 02/27/2018 17:14 PM
medication4_name NOTES, NOTES: 999= Legitimately skipped; NOTES: 0 = No medication; 999= Legitimately skipped 02/27/2018 17:14 PM
medication5_name NOTES, NOTES: NOTES: 0 = No medication; 999= Legitimately skipped 02/27/2018 17:14 PM
medication6_name NOTES, NOTES: NOTES: 0 = No medication; 999= Legitimately skipped 02/27/2018 17:14 PM
medication7_name NOTES, NOTES: NOTES: 0 = No medication; 999= Legitimately skipped 02/27/2018 17:14 PM
medication8_name NOTES, NOTES: NOTES: 0 = No medication; 999= Legitimately skipped 02/27/2018 17:14 PM
medication2_name ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 200 12/22/2017 11:58 AM
race DESCRIPTION DESCRIPTION: Race of participant DESCRIPTION: Race of study subject 12/21/2017 08:54 AM
race DESCRIPTION DESCRIPTION: Race of study subject DESCRIPTION: Race of participant 12/21/2017 08:52 AM
version_form DESCRIPTION DESCRIPTION: Form used DESCRIPTION: Form used/assessment name 11/24/2017 16:39 PM
medication11_name DESCRIPTION DESCRIPTION: Med name11 DESCRIPTION: Medication 11 name 11/22/2017 17:21 PM
interview_date DESCRIPTION DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYY DESCRIPTION: Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY 08/28/2017 15:10 PM
q1_16c1 DESCRIPTION DESCRIPTION: Medication Code DESCRIPTION: Medication Code 3 (Autism medication not previously mentioned) 08/15/2017 12:03 PM
q1_16b1 DESCRIPTION DESCRIPTION: Medication Code DESCRIPTION: Medication Code 2 (Autism medication not previously mentioned) 08/15/2017 11:58 AM
q1_16a1 DESCRIPTION DESCRIPTION: Medication Code DESCRIPTION: Medication Code 1 (Autism medication not previously mentioned) 08/15/2017 11:55 AM
q1_14d1 DESCRIPTION DESCRIPTION: Medication Code DESCRIPTION: Medication Code 4 08/14/2017 16:21 PM
q1_14e1 DESCRIPTION DESCRIPTION: Medication Code DESCRIPTION: Medication Code 5 08/14/2017 16:21 PM
q1_14f1 DESCRIPTION DESCRIPTION: Medication Code DESCRIPTION: Medication Code 6 08/14/2017 16:21 PM
q1_14g1 DESCRIPTION DESCRIPTION: Medication Code DESCRIPTION: Medication Code 7 08/14/2017 16:21 PM
q1_14h1 DESCRIPTION DESCRIPTION: Medication Code DESCRIPTION: Medication Code 8 08/14/2017 16:21 PM
q1_14i1 DESCRIPTION DESCRIPTION: Medication Code DESCRIPTION: Medication Code 9 08/14/2017 16:21 PM
q1_14a1 DESCRIPTION DESCRIPTION: Medication Code DESCRIPTION: Medication Code 1 08/14/2017 16:21 PM
q1_14b1 DESCRIPTION DESCRIPTION: Medication Code DESCRIPTION: Medication Code 2 08/14/2017 16:21 PM
q1_14c1 DESCRIPTION DESCRIPTION: Medication Code DESCRIPTION: Medication Code 3 08/14/2017 16:21 PM
version_form NOTES NOTES: 0 NOTES: 08/01/2017 15:06 PM
version_form NOTES NOTES: NOTES: 0 08/01/2017 14:25 PM
study_drug_team VALUE_RANGE, NOTES VALUE_RANGE: Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA NOTES: VALUE_RANGE: NOTES: Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA 04/25/2017 16:06 PM
sae_42 ELEMENT_SIZE ELEMENT_SIZE: 250 ELEMENT_SIZE: 500 02/09/2017 16:01 PM
stdate1 NEW_MAP_ELEMENT Added data element 'stdate1' to data structure 'sae01'. 02/08/2017 14:15 PM
outcome_of_sae1 VALUE_RANGE VALUE_RANGE: 1::( VALUE_RANGE: 1::9 02/07/2017 16:18 PM
outcome_of_sae1 VALUE_RANGE, NOTES VALUE_RANGE: 1::7 NOTES: 1=Death; 2=Resolved without sequelae; 3=Resolved with sequelae; 4=Condition still present; 5=Change in AE status/characteristic; 6=Lost to follow up; 7=Other, specify VALUE_RANGE: 1::( NOTES: 1=Death; 2=Resolved without sequelae; 3=Resolved with sequelae; 4=Condition still present; 5=Change in AE status/characteristic; 6=Lost to follow up; 7=Other, specify; 8=NK; 9=Not resolved 02/06/2017 16:30 PM
drrel VALUE_RANGE, NOTES VALUE_RANGE: 0;1;-3 NOTES: 0=No; 1=Yes; -3=Unknown at this time VALUE_RANGE: 0::4;-3 NOTES: 0=No; 1=Yes; -3=Unknown at this time; 2=Probably; 3=Possibly; 4=Remotely 02/06/2017 16:28 PM
saea17 VALUE_RANGE, NOTES VALUE_RANGE: A;B;C;D;E;F NOTES: A=None; B=Discontinued; C=Interrupted Study Treatment; D=Dose Adjusted; Not Applicable; F=Unknown at this time VALUE_RANGE: A;B;C;D;E;F;G;H;I NOTES: A=None; B=Discontinued; C=Interrupted Study Treatment; D=Dose Adjusted; Not Applicable; F=Unknown at this time; G=Reduced Dose; H=Increased Dose; I=Delayed Dose 02/06/2017 16:28 PM
suspect VALUE_RANGE, NOTES VALUE_RANGE: 0::2 NOTES: 0=No;1=Yes;2=Maybe VALUE_RANGE: 0::5 NOTES: 0=No;1=Yes;2=Maybe;3=Probably; 4=Possibly; 5=Remotely 02/06/2017 16:28 PM
height_met NEW_MAP_ELEMENT Added data element 'height_met' to data structure 'sae01'. 02/06/2017 16:23 PM
lab020 NEW_MAP_ELEMENT Added data element 'lab020' to data structure 'sae01'. 02/06/2017 16:23 PM
medication2_start NEW_MAP_ELEMENT Added data element 'medication2_start' to data structure 'sae01'. 02/06/2017 16:23 PM
medication3_start NEW_MAP_ELEMENT Added data element 'medication3_start' to data structure 'sae01'. 02/06/2017 16:23 PM
medication3_stop NEW_MAP_ELEMENT Added data element 'medication3_stop' to data structure 'sae01'. 02/06/2017 16:23 PM
medication4_start NEW_MAP_ELEMENT Added data element 'medication4_start' to data structure 'sae01'. 02/06/2017 16:23 PM
medication4_stop NEW_MAP_ELEMENT Added data element 'medication4_stop' to data structure 'sae01'. 02/06/2017 16:23 PM
medication5_start NEW_MAP_ELEMENT Added data element 'medication5_start' to data structure 'sae01'. 02/06/2017 16:23 PM
medication5_stop NEW_MAP_ELEMENT Added data element 'medication5_stop' to data structure 'sae01'. 02/06/2017 16:23 PM
medication6_start NEW_MAP_ELEMENT Added data element 'medication6_start' to data structure 'sae01'. 02/06/2017 16:23 PM
medication6_stop NEW_MAP_ELEMENT Added data element 'medication6_stop' to data structure 'sae01'. 02/06/2017 16:23 PM
q53_b1a NEW_MAP_ELEMENT Added data element 'q53_b1a' to data structure 'sae01'. 02/06/2017 16:23 PM
q53_b6f2 NEW_MAP_ELEMENT Added data element 'q53_b6f2' to data structure 'sae01'. 02/06/2017 16:23 PM
route5 NEW_MAP_ELEMENT Added data element 'route5' to data structure 'sae01'. 02/06/2017 16:23 PM
route6 NEW_MAP_ELEMENT Added data element 'route6' to data structure 'sae01'. 02/06/2017 16:23 PM
strmedend1 NEW_MAP_ELEMENT Added data element 'strmedend1' to data structure 'sae01'. 02/06/2017 16:23 PM
ca17 NEW_MAP_ELEMENT Added data element 'ca17' to data structure 'sae01'. 02/06/2017 16:23 PM
vis_type VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: 1=Phone; 0=doctor's office VALUE_RANGE: 0::2 NOTES: 1=Phone; 0=doctor's office; 2=No, not phone interview 02/02/2017 17:01 PM
version_form ELEMENT_SIZE ELEMENT_SIZE: 50 ELEMENT_SIZE: 100 02/02/2017 16:38 PM
ddose NOTES NOTES: -9=unknown NOTES: -9=unknown 02/02/2017 11:27 AM
gender REQUIRED REQUIRED: Recommended REQUIRED: Required 01/27/2017 11:09 AM
interview_age REQUIRED REQUIRED: Recommended REQUIRED: Required 01/27/2017 11:09 AM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 01/27/2017 11:09 AM
gender REQUIRED REQUIRED: Required REQUIRED: Recommended 01/27/2017 10:40 AM
interview_age REQUIRED REQUIRED: Required REQUIRED: Recommended 01/27/2017 10:40 AM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 01/27/2017 10:40 AM
gender REQUIRED REQUIRED: Recommended REQUIRED: Required 01/26/2017 17:29 PM
interview_age REQUIRED REQUIRED: Recommended REQUIRED: Required 01/26/2017 17:29 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 01/26/2017 17:29 PM
gender REQUIRED REQUIRED: Required REQUIRED: Recommended 01/26/2017 16:56 PM
interview_age REQUIRED REQUIRED: Required REQUIRED: Recommended 01/26/2017 16:56 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 01/26/2017 16:56 PM
gender REQUIRED REQUIRED: Recommended REQUIRED: Required 01/25/2017 17:26 PM
interview_age REQUIRED REQUIRED: Recommended REQUIRED: Required 01/25/2017 17:26 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 01/25/2017 17:26 PM
gender REQUIRED REQUIRED: Required REQUIRED: Recommended 01/25/2017 16:50 PM
interview_age REQUIRED REQUIRED: Required REQUIRED: Recommended 01/25/2017 16:50 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 01/25/2017 16:50 PM
aespdtm NEW_MAP_ELEMENT Added data element 'aespdtm' to data structure 'sae01'. 01/25/2017 15:47 PM
rand_num NEW_MAP_ELEMENT Added data element 'rand_num' to data structure 'sae01'. 01/25/2017 15:47 PM
sae_permseq NEW_DATA_ELEMENT 01/25/2017 15:47 PM
sae_permseq NEW_MAP_ELEMENT Added data element 'sae_permseq' to data structure 'sae01'. 01/25/2017 15:47 PM
sae_randmed NEW_DATA_ELEMENT 01/25/2017 15:47 PM
sae_randmed NEW_MAP_ELEMENT Added data element 'sae_randmed' to data structure 'sae01'. 01/25/2017 15:47 PM
sae_random NEW_DATA_ELEMENT 01/25/2017 15:47 PM
sae_random NEW_MAP_ELEMENT Added data element 'sae_random' to data structure 'sae01'. 01/25/2017 15:47 PM
intensty VALUE_RANGE, NOTES VALUE_RANGE: NOTES: Ignore: = missing for all records VALUE_RANGE: 1::3 NOTES: 1=mild; 2=moderate; 3=serious 01/25/2017 15:36 PM
lab020 DESCRIPTION DESCRIPTION: Date of PI signature DESCRIPTION: Date of PI/clinician signature 01/17/2017 17:54 PM
study_drug_team VALUE_RANGE VALUE_RANGE: Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA VALUE_RANGE: Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA 12/13/2016 15:24 PM
medication3_name ELEMENT_SIZE ELEMENT_SIZE: 100 ELEMENT_SIZE: 150 12/12/2016 11:37 AM
study_drug_team VALUE_RANGE VALUE_RANGE: Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline VALUE_RANGE: Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA 12/09/2016 18:18 PM
adl_q04 NOTES NOTES: NOTES: -888=NA 12/09/2016 18:18 PM
description_of_sae ELEMENT_SIZE ELEMENT_SIZE: 250 ELEMENT_SIZE: 300 11/30/2016 11:19 AM
gender REQUIRED REQUIRED: Recommended REQUIRED: Required 10/13/2016 13:26 PM
interview_age REQUIRED REQUIRED: Recommended REQUIRED: Required 10/13/2016 13:26 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 10/13/2016 13:26 PM
gender REQUIRED REQUIRED: Required REQUIRED: Recommended 10/13/2016 13:04 PM
interview_age REQUIRED REQUIRED: Required REQUIRED: Recommended 10/13/2016 13:04 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 10/13/2016 13:04 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 10/11/2016 13:24 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 10/11/2016 13:10 PM
study_drug_team VALUE_RANGE VALUE_RANGE: Baseline; Risperidone; Valproate; Lithium VALUE_RANGE: Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline 10/06/2016 17:47 PM
sae_25e NEW_MAP_ELEMENT Added data element 'sae_25e' to data structure 'sae01'. 10/06/2016 17:32 PM
sae_ro NEW_MAP_ELEMENT Added data element 'sae_ro' to data structure 'sae01'. 10/06/2016 17:32 PM
sae_16c NEW_MAP_ELEMENT Added data element 'sae_16c' to data structure 'sae01'. 10/06/2016 17:32 PM
sae_17c NEW_MAP_ELEMENT Added data element 'sae_17c' to data structure 'sae01'. 10/06/2016 17:32 PM
sae_23e NEW_MAP_ELEMENT Added data element 'sae_23e' to data structure 'sae01'. 10/06/2016 17:32 PM
sae_24e NEW_MAP_ELEMENT Added data element 'sae_24e' to data structure 'sae01'. 10/06/2016 17:32 PM
sae_cte NEW_MAP_ELEMENT Added data element 'sae_cte' to data structure 'sae01'. 10/06/2016 17:32 PM
study_drug_team NEW_MAP_ELEMENT Added data element 'study_drug_team' to data structure 'sae01'. 10/06/2016 17:32 PM
v1_mh_cap5_startdate NEW_MAP_ELEMENT Added data element 'v1_mh_cap5_startdate' to data structure 'sae01'. 10/06/2016 17:32 PM
inilspec NEW_MAP_ELEMENT Added data element 'inilspec' to data structure 'sae01'. 10/06/2016 17:32 PM
ptdose NEW_MAP_ELEMENT Added data element 'ptdose' to data structure 'sae01'. 10/06/2016 17:32 PM
race NEW_MAP_ELEMENT Added data element 'race' to data structure 'sae01'. 10/06/2016 17:32 PM
sae_16c NEW_DATA_ELEMENT 10/06/2016 17:32 PM
sae_17c NEW_DATA_ELEMENT 10/06/2016 17:32 PM
sae_23e NEW_DATA_ELEMENT 10/06/2016 17:32 PM
sae_24e NEW_DATA_ELEMENT 10/06/2016 17:32 PM
sae_25e NEW_DATA_ELEMENT 10/06/2016 17:32 PM
sae_cte NEW_DATA_ELEMENT 10/06/2016 17:32 PM
sae_ro NEW_DATA_ELEMENT 10/06/2016 17:32 PM
lot_number NOTES NOTES: NOTES: Yes = Lot Number Known 09/26/2016 16:55 PM
reappear VALUE_RANGE, NOTES VALUE_RANGE: 0::2; 999 NOTES: 1=Yes; 0=No; 2=did not reintroduce; 999=Legitimately skipped VALUE_RANGE: 0::2; 999; -8 NOTES: 1=Yes; 0=No; 2=did not reintroduce; 999=Legitimately skipped; -8=NA 09/26/2016 16:54 PM
ldosedy NEW_MAP_ELEMENT Added data element 'ldosedy' to data structure 'sae01'. 09/23/2016 17:17 PM
lot_number NEW_MAP_ELEMENT Added data element 'lot_number' to data structure 'sae01'. 09/23/2016 17:17 PM
sae_12edo_day NEW_MAP_ELEMENT Added data element 'sae_12edo_day' to data structure 'sae01'. 09/23/2016 17:17 PM
sae_12edob_day NEW_MAP_ELEMENT Added data element 'sae_12edob_day' to data structure 'sae01'. 09/23/2016 17:17 PM
sae_9day NEW_MAP_ELEMENT Added data element 'sae_9day' to data structure 'sae01'. 09/23/2016 17:17 PM
adl_q04 NEW_MAP_ELEMENT Added data element 'adl_q04' to data structure 'sae01'. 09/23/2016 17:16 PM
mtype NEW_MAP_ELEMENT Added data element 'mtype' to data structure 'sae01'. 09/23/2016 17:16 PM
sae_9 NEW_MAP_ELEMENT Added data element 'sae_9' to data structure 'sae01'. 09/23/2016 17:16 PM
sae_12edo_day NEW_DATA_ELEMENT 09/23/2016 17:16 PM
sae_12edob_day NEW_DATA_ELEMENT 09/23/2016 17:16 PM
sae_9 NEW_DATA_ELEMENT 09/23/2016 17:16 PM
sae_9day NEW_DATA_ELEMENT 09/23/2016 17:16 PM
saerl VALUE_RANGE, NOTES VALUE_RANGE: A; B; C;D; E NOTES: A=Not related; B=Possible; C=Probably; D=Definitely; E= Unknown at this time VALUE_RANGE: A; B; C;D; E; F NOTES: A=Not related; B=Possible; C=Probably; D=Definitely; E= Unknown at this time; F=N/A 09/22/2016 18:09 PM
mtype VALUE_RANGE, NOTES VALUE_RANGE: 1;2 NOTES: 1=Li; 2=NTP VALUE_RANGE: 1::4 NOTES: 1=Li; 2=NTP; 3 = Other psychiatric medication, 4 = Non-psychiatric medication 09/15/2016 12:03 PM
action VALUE_RANGE, NOTES VALUE_RANGE: A; B; C;D; E; F; G;U NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued; U=unknown VALUE_RANGE: A; B; C;D; E; F; G;U; H NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued; U=unknown; H=Dose increased 09/15/2016 12:02 PM
v1_mh_cap5_startdate NEW_DATA_ELEMENT 08/15/2016 15:28 PM
q1_14a1 VALUE_RANGE VALUE_RANGE: 001 :: 2099 VALUE_RANGE: 1 :: 2099 07/14/2016 16:01 PM
q1_14b1 VALUE_RANGE VALUE_RANGE: 001 :: 2099 VALUE_RANGE: 1 :: 2099 07/14/2016 16:01 PM
q1_14c1 VALUE_RANGE VALUE_RANGE: 001 :: 2099 VALUE_RANGE: 1 :: 2099 07/14/2016 16:01 PM
q1_14d1 VALUE_RANGE VALUE_RANGE: 001 :: 2099 VALUE_RANGE: 1 :: 2099 07/14/2016 16:01 PM
q1_14e1 VALUE_RANGE VALUE_RANGE: 001 :: 2099 VALUE_RANGE: 1 :: 2099 07/14/2016 16:01 PM
q1_14f1 VALUE_RANGE VALUE_RANGE: 001 :: 2099 VALUE_RANGE: 1 :: 2099 07/14/2016 16:01 PM
q1_14g1 VALUE_RANGE VALUE_RANGE: 001 :: 2099 VALUE_RANGE: 1 :: 2099 07/14/2016 16:01 PM
q1_14h1 VALUE_RANGE VALUE_RANGE: 001 :: 2099 VALUE_RANGE: 1 :: 2099 07/14/2016 16:01 PM
q1_14i1 VALUE_RANGE VALUE_RANGE: 001 :: 2099 VALUE_RANGE: 1 :: 2099 07/14/2016 16:01 PM
q1_16a1 VALUE_RANGE VALUE_RANGE: 001 :: 2099 VALUE_RANGE: 1 :: 2099 07/14/2016 16:01 PM
q1_16b1 VALUE_RANGE VALUE_RANGE: 001 :: 2099 VALUE_RANGE: 1 :: 2099 07/14/2016 16:01 PM
q1_16c1 VALUE_RANGE VALUE_RANGE: 001 :: 2099 VALUE_RANGE: 1 :: 2099 07/14/2016 16:01 PM
q1_14a1 VALUE_RANGE VALUE_RANGE: 101 :: 2099 VALUE_RANGE: 001 :: 2099 07/14/2016 15:25 PM
q1_14c1 VALUE_RANGE VALUE_RANGE: 101 :: 2099 VALUE_RANGE: 001 :: 2099 07/14/2016 15:25 PM
q1_14d1 VALUE_RANGE VALUE_RANGE: 101 :: 2099 VALUE_RANGE: 001 :: 2099 07/14/2016 15:25 PM
q1_14e1 VALUE_RANGE VALUE_RANGE: 101 :: 2099 VALUE_RANGE: 001 :: 2099 07/14/2016 15:25 PM
q1_14f1 VALUE_RANGE VALUE_RANGE: 101 :: 2099 VALUE_RANGE: 001 :: 2099 07/14/2016 15:25 PM
q1_14g1 VALUE_RANGE VALUE_RANGE: 101 :: 2099 VALUE_RANGE: 001 :: 2099 07/14/2016 15:25 PM
q1_14h1 VALUE_RANGE VALUE_RANGE: 101 :: 2099 VALUE_RANGE: 001 :: 2099 07/14/2016 15:25 PM
q1_14i1 VALUE_RANGE VALUE_RANGE: 101 :: 2099 VALUE_RANGE: 001 :: 2099 07/14/2016 15:25 PM
q1_16a1 VALUE_RANGE VALUE_RANGE: 101 :: 2099 VALUE_RANGE: 001 :: 2099 07/14/2016 15:25 PM
q1_16b1 VALUE_RANGE VALUE_RANGE: 101 :: 2099 VALUE_RANGE: 001 :: 2099 07/14/2016 15:25 PM
q1_16c1 VALUE_RANGE VALUE_RANGE: 101 :: 2099 VALUE_RANGE: 001 :: 2099 07/14/2016 15:25 PM
q1_14b1 VALUE_RANGE VALUE_RANGE: 101 :: 2099 VALUE_RANGE: 001 :: 2099 07/14/2016 15:25 PM
race DESCRIPTION DESCRIPTION: Race of participant DESCRIPTION: Race of study subject 07/12/2016 16:49 PM
version_form ELEMENT_SIZE ELEMENT_SIZE: 20 ELEMENT_SIZE: 50 07/11/2016 14:45 PM
rand_num NEW_DATA_ELEMENT 06/20/2016 10:47 AM
cont7 NOTES NOTES: 0=No; 1=Yes; -7=Refused NOTES: 0=No (discontinued); 1=Yes; -7=Refused 06/09/2016 11:38 AM
cont8 NOTES NOTES: 0=No; 1=Yes; -7=Refused NOTES: 0=No (discontinued); 1=Yes; -7=Refused 06/09/2016 11:38 AM
cont9 NOTES NOTES: 0=No; 1=Yes; -7=Refused NOTES: 0=No (discontinued); 1=Yes; -7=Refused 06/09/2016 11:38 AM
cont3 NOTES NOTES: 0=No; 1=Yes; -7=Refused NOTES: 0=No (discontinued); 1=Yes; -7=Refused 06/09/2016 11:38 AM
cont4 NOTES NOTES: 0=No; 1=Yes; -7=Refused NOTES: 0=No (discontinued); 1=Yes; -7=Refused 06/09/2016 11:38 AM
cont5 NOTES NOTES: 0=No; 1=Yes; -7=Refused NOTES: 0=No (discontinued); 1=Yes; -7=Refused 06/09/2016 11:38 AM
cont6 NOTES NOTES: 0=No; 1=Yes; -7=Refused NOTES: 0=No (discontinued); 1=Yes; -7=Refused 06/09/2016 11:38 AM
cont12 NOTES NOTES: 0=No; 1=Yes; -7=Refused NOTES: 0=No (discontinued); 1=Yes; -7=Refused 06/09/2016 11:38 AM
cont2 NOTES NOTES: 0=No; 1=Yes; -7=Refused NOTES: 0=No (discontinued); 1=Yes; -7=Refused 06/09/2016 11:38 AM
cont10 NOTES NOTES: 0=No; 1=Yes; -7=Refused NOTES: 0=No (discontinued); 1=Yes; -7=Refused 06/09/2016 11:38 AM
cont11 NOTES NOTES: 0=No; 1=Yes; -7=Refused NOTES: 0=No (discontinued); 1=Yes; -7=Refused 06/09/2016 11:38 AM
cont1 NOTES NOTES: 0=No; 1=Yes; -7=Refused NOTES: 0=No (discontinued); 1=Yes; -7=Refused 06/09/2016 11:38 AM
medication3_name NOTES NOTES: Add 999= Legitimately skipped; NOTES: 999= Legitimately skipped; 05/31/2016 10:23 AM
medication4_name NOTES NOTES: Add 999= Legitimately skipped; NOTES: 999= Legitimately skipped; 05/31/2016 10:23 AM
medication2_name NOTES NOTES: Add 999= Legitimately skipped; NOTES: 999= Legitimately skipped; 05/31/2016 10:23 AM
medication1_name NOTES NOTES: Add 999= Legitimately skipped; NOTES: 999= Legitimately skipped; 05/31/2016 10:23 AM
gender VALUE_RANGE, NOTES VALUE_RANGE: M;F; T NOTES: M = Male; F = Female; T= Transgender VALUE_RANGE: M;F NOTES: M = Male; F = Female 05/25/2016 11:51 AM
gender DESCRIPTION DESCRIPTION: Gender DESCRIPTION: Sex of the subject 05/25/2016 11:50 AM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 04/21/2016 14:56 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 04/21/2016 14:47 PM
q53_a3a VALUE_RANGE VALUE_RANGE: -7;-8;-9; 20 :: 250 VALUE_RANGE: -7;-8;-9; 20 :: 400 04/20/2016 17:32 PM
causal VALUE_RANGE, NOTES VALUE_RANGE: 1::3;-7 NOTES: 1=Associated with study drug; 2=Unknown; 3=Not associated with study drug; -7=Refused VALUE_RANGE: 1::5;-7 NOTES: 1=Associated with study drug; 2=Unknown; 3=Not associated with study drug; -7=Refused; 4=Concomitant Drug; 5=Disease under Study; 6=Other Illness 04/20/2016 17:31 PM
offstime NEW_MAP_ELEMENT Added data element 'offstime' to data structure 'sae01'. 03/24/2016 13:52 PM
saerecur NEW_MAP_ELEMENT Added data element 'saerecur' to data structure 'sae01'. 03/24/2016 13:52 PM
medreint NEW_DATA_ELEMENT 03/24/2016 13:52 PM
medreint NEW_MAP_ELEMENT Added data element 'medreint' to data structure 'sae01'. 03/24/2016 13:52 PM
offstime NEW_DATA_ELEMENT 03/24/2016 13:52 PM
q53_a3a NEW_MAP_ELEMENT Added data element 'q53_a3a' to data structure 'sae01'. 03/24/2016 13:52 PM
recoverydays NEW_MAP_ELEMENT Added data element 'recoverydays' to data structure 'sae01'. 03/24/2016 13:52 PM
reinte NEW_MAP_ELEMENT Added data element 'reinte' to data structure 'sae01'. 03/24/2016 13:52 PM
withdrawn NEW_MAP_ELEMENT Added data element 'withdrawn' to data structure 'sae01'. 03/24/2016 13:52 PM
reinte NEW_DATA_ELEMENT 03/24/2016 13:52 PM
saerecur NEW_DATA_ELEMENT 03/24/2016 13:52 PM
withdrawn NEW_DATA_ELEMENT 03/18/2016 11:13 AM
saea19 VALUE_RANGE VALUE_RANGE: A;B;C;D: E; F; U VALUE_RANGE: A;B;C;D;E;F;U 10/06/2015 18:04 PM
aespdtm NEW_DATA_ELEMENT 09/30/2015 17:13 PM
inilspec NEW_DATA_ELEMENT 09/30/2015 17:13 PM
action VALUE_RANGE, NOTES VALUE_RANGE: A; B; C;D; E; F; G NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued VALUE_RANGE: A; B; C;D; E; F; G;U NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued; U=unknown 09/30/2015 17:12 PM
saea19 VALUE_RANGE, NOTES VALUE_RANGE: A;B;C;D NOTES: A=Died; B=Ongoing; C=Recovered; D=Recovered with sequeale VALUE_RANGE: A;B;C;D: E; F; U NOTES: A=Died; B=Ongoing; C=Recovered; D=Recovered with sequelae;E=Not recovered; F=Recovering; U=Unknown 09/30/2015 17:12 PM
recoverydays NEW_DATA_ELEMENT 09/24/2015 14:33 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 07/30/2015 12:55 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 07/30/2015 12:48 PM
gender REQUIRED REQUIRED: Recommended REQUIRED: Required 07/23/2015 11:32 AM
saerl VALUE_RANGE, NOTES VALUE_RANGE: A; B; C;D NOTES: A=Not related; B=Possible; C=Probably; D=Definitely VALUE_RANGE: A; B; C;D; E NOTES: A=Not related; B=Possible; C=Probably; D=Definitely; E= Unknown at this time 07/22/2015 15:43 PM
reappear VALUE_RANGE, NOTES VALUE_RANGE: 0::2 NOTES: 1=Yes; 0=No; 2=did not reintroduce VALUE_RANGE: 0::2; 999 NOTES: 1=Yes; 0=No; 2=did not reintroduce; 999=Legitimately skipped 07/22/2015 15:43 PM
abate VALUE_RANGE, NOTES VALUE_RANGE: 0::2 NOTES: 0=No; 1= Yes; 2=NA VALUE_RANGE: 0::2; 999 NOTES: 0=No; 1= Yes; 2=NA; 999=Legitimately skipped 07/22/2015 15:42 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 07/22/2015 12:41 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 07/22/2015 12:37 PM
lhq_hosp2 NEW_MAP_ELEMENT Added data element 'lhq_hosp2' to data structure 'sae01'. 07/21/2015 17:57 PM
type_hosp NEW_DATA_ELEMENT 07/21/2015 17:57 PM
type_hosp NEW_MAP_ELEMENT Added data element 'type_hosp' to data structure 'sae01'. 07/21/2015 17:57 PM
action_taken1 NEW_MAP_ELEMENT Added data element 'action_taken1' to data structure 'sae01'. 07/14/2015 18:00 PM
outcome_of_sae1 NEW_MAP_ELEMENT Added data element 'outcome_of_sae1' to data structure 'sae01'. 07/14/2015 18:00 PM
parent_id NEW_MAP_ELEMENT Added data element 'parent_id' to data structure 'sae01'. 07/14/2015 18:00 PM
action_taken1 NEW_DATA_ELEMENT 07/14/2015 18:00 PM
date_updated NEW_MAP_ELEMENT Added data element 'date_updated' to data structure 'sae01'. 07/14/2015 18:00 PM
outcome_of_sae1 NEW_DATA_ELEMENT 07/14/2015 18:00 PM
parent_id NEW_DATA_ELEMENT 07/14/2015 18:00 PM
subject_description DESCRIPTION DESCRIPTION: Subject related information (e.g the affectation phenotype, disease information, etc.). DESCRIPTION: Subject related information (e.g the affection, phenotype, disease information, etc.). 06/23/2015 17:09 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 06/18/2015 13:04 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 06/18/2015 12:39 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 06/18/2015 10:25 AM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 06/18/2015 10:06 AM
vis_type NEW_MAP_ELEMENT Added data element 'vis_type' to data structure 'sae01'. 06/17/2015 17:42 PM
timeampm NEW_DATA_ELEMENT 06/17/2015 17:42 PM
timeampm NEW_MAP_ELEMENT Added data element 'timeampm' to data structure 'sae01'. 06/17/2015 17:42 PM
saea15b VALUE_RANGE VALUE_RANGE: 0::200 VALUE_RANGE: 0::230 06/16/2015 18:23 PM
lhq_hosp2 NEW_DATA_ELEMENT 06/15/2015 18:40 PM
labtest3 NEW_MAP_ELEMENT Added data element 'labtest3' to data structure 'sae01'. 06/10/2015 18:11 PM
labtest4 NEW_MAP_ELEMENT Added data element 'labtest4' to data structure 'sae01'. 06/10/2015 18:11 PM
phase_ct NEW_MAP_ELEMENT Added data element 'phase_ct' to data structure 'sae01'. 06/10/2015 18:11 PM
result3 NEW_MAP_ELEMENT Added data element 'result3' to data structure 'sae01'. 06/10/2015 18:11 PM
result4 NEW_MAP_ELEMENT Added data element 'result4' to data structure 'sae01'. 06/10/2015 18:11 PM
tstdate3 NEW_MAP_ELEMENT Added data element 'tstdate3' to data structure 'sae01'. 06/10/2015 18:11 PM
tstdate4 NEW_MAP_ELEMENT Added data element 'tstdate4' to data structure 'sae01'. 06/10/2015 18:11 PM
conmed5 NEW_MAP_ELEMENT Added data element 'conmed5' to data structure 'sae01'. 06/10/2015 18:11 PM
labtest1 NEW_MAP_ELEMENT Added data element 'labtest1' to data structure 'sae01'. 06/10/2015 18:11 PM
labtest2 NEW_MAP_ELEMENT Added data element 'labtest2' to data structure 'sae01'. 06/10/2015 18:11 PM
result1 NEW_MAP_ELEMENT Added data element 'result1' to data structure 'sae01'. 06/10/2015 18:11 PM
result2 NEW_MAP_ELEMENT Added data element 'result2' to data structure 'sae01'. 06/10/2015 18:11 PM
tstdate1 NEW_MAP_ELEMENT Added data element 'tstdate1' to data structure 'sae01'. 06/10/2015 18:11 PM
tstdate2 NEW_MAP_ELEMENT Added data element 'tstdate2' to data structure 'sae01'. 06/10/2015 18:11 PM
conmed1 NEW_MAP_ELEMENT Added data element 'conmed1' to data structure 'sae01'. 06/10/2015 18:11 PM
conmed2 NEW_MAP_ELEMENT Added data element 'conmed2' to data structure 'sae01'. 06/10/2015 18:11 PM
conmed3 NEW_MAP_ELEMENT Added data element 'conmed3' to data structure 'sae01'. 06/10/2015 18:11 PM
conmed4 NEW_MAP_ELEMENT Added data element 'conmed4' to data structure 'sae01'. 06/10/2015 18:11 PM
hi_31e5 NEW_MAP_ELEMENT Added data element 'hi_31e5' to data structure 'sae01'. 06/10/2015 18:11 PM
hi_31e6 NEW_MAP_ELEMENT Added data element 'hi_31e6' to data structure 'sae01'. 06/10/2015 18:11 PM
q53_b6e2 NEW_MAP_ELEMENT Added data element 'q53_b6e2' to data structure 'sae01'. 06/10/2015 18:11 PM
suspect NEW_MAP_ELEMENT Added data element 'suspect' to data structure 'sae01'. 06/10/2015 18:11 PM
hi_31c5 NEW_MAP_ELEMENT Added data element 'hi_31c5' to data structure 'sae01'. 06/10/2015 18:11 PM
hi_31c6 NEW_MAP_ELEMENT Added data element 'hi_31c6' to data structure 'sae01'. 06/10/2015 18:11 PM
hi_31d5 NEW_MAP_ELEMENT Added data element 'hi_31d5' to data structure 'sae01'. 06/10/2015 18:11 PM
hi_31d6 NEW_MAP_ELEMENT Added data element 'hi_31d6' to data structure 'sae01'. 06/10/2015 18:11 PM
medication4_route NEW_MAP_ELEMENT Added data element 'medication4_route' to data structure 'sae01'. 06/10/2015 18:11 PM
medication5_route NEW_MAP_ELEMENT Added data element 'medication5_route' to data structure 'sae01'. 06/10/2015 18:11 PM
q53_b6d2 NEW_MAP_ELEMENT Added data element 'q53_b6d2' to data structure 'sae01'. 06/10/2015 18:11 PM
hi_31a6 NEW_MAP_ELEMENT Added data element 'hi_31a6' to data structure 'sae01'. 06/10/2015 18:11 PM
hi_31b5 NEW_MAP_ELEMENT Added data element 'hi_31b5' to data structure 'sae01'. 06/10/2015 18:11 PM
hi_31b6 NEW_MAP_ELEMENT Added data element 'hi_31b6' to data structure 'sae01'. 06/10/2015 18:11 PM
medication2_route NEW_MAP_ELEMENT Added data element 'medication2_route' to data structure 'sae01'. 06/10/2015 18:11 PM
medication3_route NEW_MAP_ELEMENT Added data element 'medication3_route' to data structure 'sae01'. 06/10/2015 18:11 PM
q53_b6b2 NEW_MAP_ELEMENT Added data element 'q53_b6b2' to data structure 'sae01'. 06/10/2015 18:11 PM
q53_b6c2 NEW_MAP_ELEMENT Added data element 'q53_b6c2' to data structure 'sae01'. 06/10/2015 18:11 PM
conmed1 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
conmed2 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
conmed3 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
conmed4 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
conmed5 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
hi_31a5 NEW_MAP_ELEMENT Added data element 'hi_31a5' to data structure 'sae01'. 06/10/2015 18:11 PM
labtest1 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
labtest2 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
labtest3 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
labtest4 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
medication1_route NEW_MAP_ELEMENT Added data element 'medication1_route' to data structure 'sae01'. 06/10/2015 18:11 PM
q53_b6a2 NEW_MAP_ELEMENT Added data element 'q53_b6a2' to data structure 'sae01'. 06/10/2015 18:11 PM
result1 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
result2 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
result3 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
result4 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
suspect NEW_DATA_ELEMENT 06/10/2015 18:11 PM
tstdate1 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
tstdate2 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
tstdate3 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
tstdate4 NEW_DATA_ELEMENT 06/10/2015 18:11 PM
unblind NEW_DATA_ELEMENT 06/10/2015 18:11 PM
unblind NEW_MAP_ELEMENT Added data element 'unblind' to data structure 'sae01'. 06/10/2015 18:11 PM
weight_std NEW_MAP_ELEMENT Added data element 'weight_std' to data structure 'sae01'. 06/10/2015 18:11 PM
ddose NOTES NOTES: NOTES: -9=unknown 06/04/2015 16:43 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 06/04/2015 16:35 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 06/04/2015 16:23 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 06/04/2015 15:13 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 06/04/2015 14:26 PM
action VALUE_RANGE, NOTES VALUE_RANGE: A; B; C;D NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable VALUE_RANGE: A; B; C;D; E; F; G NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued 06/03/2015 16:33 PM
interview_date DESCRIPTION DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYY DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYY 06/02/2015 17:40 PM
interview_date DESCRIPTION DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYY 06/02/2015 17:40 PM
interview_age REQUIRED REQUIRED: Recommended REQUIRED: Required 06/02/2015 17:24 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 06/02/2015 17:24 PM
interview_age REQUIRED REQUIRED: Required REQUIRED: Recommended 06/02/2015 17:22 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 06/02/2015 17:22 PM
interview_age VALUE_RANGE VALUE_RANGE: 0 :: 1200 VALUE_RANGE: 0 :: 1260 06/01/2015 14:16 PM
prf_term ELEMENT_SIZE ELEMENT_SIZE: 50 ELEMENT_SIZE: 100 06/01/2015 13:22 PM
eoc_day NEW_MAP_ELEMENT Added data element 'eoc_day' to data structure 'sae01'. 05/29/2015 14:51 PM
b1_day NEW_MAP_ELEMENT Added data element 'b1_day' to data structure 'sae01'. 05/29/2015 14:51 PM
b2_day NEW_MAP_ELEMENT Added data element 'b2_day' to data structure 'sae01'. 05/29/2015 14:51 PM
b3_day NEW_MAP_ELEMENT Added data element 'b3_day' to data structure 'sae01'. 05/29/2015 14:51 PM
boc_day NEW_MAP_ELEMENT Added data element 'boc_day' to data structure 'sae01'. 05/29/2015 14:51 PM
e1_day NEW_MAP_ELEMENT Added data element 'e1_day' to data structure 'sae01'. 05/29/2015 14:51 PM
e2_day NEW_MAP_ELEMENT Added data element 'e2_day' to data structure 'sae01'. 05/29/2015 14:51 PM
e3_day NEW_MAP_ELEMENT Added data element 'e3_day' to data structure 'sae01'. 05/29/2015 14:51 PM
relatoc NEW_MAP_ELEMENT Added data element 'relatoc' to data structure 'sae01'. 05/29/2015 14:51 PM
actionoc NEW_DATA_ELEMENT 05/29/2015 14:51 PM
actionoc NEW_MAP_ELEMENT Added data element 'actionoc' to data structure 'sae01'. 05/29/2015 14:51 PM
anysaeoc NEW_DATA_ELEMENT 05/29/2015 14:51 PM
anysaeoc NEW_MAP_ELEMENT Added data element 'anysaeoc' to data structure 'sae01'. 05/29/2015 14:51 PM
boc_day NEW_DATA_ELEMENT 05/29/2015 14:51 PM
durtrtoc NEW_DATA_ELEMENT 05/29/2015 14:51 PM
durtrtoc NEW_MAP_ELEMENT Added data element 'durtrtoc' to data structure 'sae01'. 05/29/2015 14:51 PM
eoc_day NEW_DATA_ELEMENT 05/29/2015 14:51 PM
phaseoc NEW_DATA_ELEMENT 05/29/2015 14:51 PM
phaseoc NEW_MAP_ELEMENT Added data element 'phaseoc' to data structure 'sae01'. 05/29/2015 14:51 PM
relatoc NEW_DATA_ELEMENT 05/29/2015 14:51 PM
rpttp NOTES NOTES: "1=Initial, 2=Follow-up"; 3=Unresolved at 1 week; 4=Final Report; NOTES: "1=Initial, 2=Follow-up"; 3=Unresolved at 1 week; 4=Final Report; 05/29/2015 13:34 PM
saea15b DESCRIPTION DESCRIPTION: If yes, Current Study Drug Stop Date [days since randomization]: DESCRIPTION: If yes, Current Study Drug Stop Date [days since randomization]: 05/29/2015 13:31 PM
saea7a DESCRIPTION DESCRIPTION: If yes, Date Event Resolved [days since randomization]: DESCRIPTION: If yes, Date Event Resolved [days since randomization]: 05/29/2015 13:31 PM
saea17 DESCRIPTION DESCRIPTION: Action taken regarding study drug: DESCRIPTION: Action taken regarding study drug: 05/29/2015 13:31 PM
comments_misc DESCRIPTION DESCRIPTION: Miscellaneous comments on study, interview, methodology relevant to this form data DESCRIPTION: Miscellaneous comments on study, interview, methodology relevant to this form data 05/29/2015 13:29 PM
phase_ct VALUE_RANGE VALUE_RANGE: Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase VALUE_RANGE: Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1 05/28/2015 18:32 PM
phase_ct VALUE_RANGE VALUE_RANGE: Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B VALUE_RANGE: Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase 05/28/2015 12:11 PM
interview_age REQUIRED REQUIRED: Recommended REQUIRED: Required 05/26/2015 17:17 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 05/26/2015 17:17 PM
interview_age REQUIRED REQUIRED: Required REQUIRED: Recommended 05/26/2015 14:52 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 05/26/2015 14:52 PM
site ELEMENT_SIZE ELEMENT_SIZE: 20 ELEMENT_SIZE: 100 05/26/2015 11:15 AM
rpttp VALUE_RANGE, NOTES VALUE_RANGE: 1;2 NOTES: "1=Initial, 2=Follow-up" VALUE_RANGE: 1::4 NOTES: "1=Initial, 2=Follow-up"; 3=Unresolved at 1 week; 4=Final Report; 05/21/2015 15:11 PM
week NOTES NOTES: NOTES: 99=week 10-week 14 05/19/2015 18:30 PM
phase NEW_MAP_ELEMENT Added data element 'phase' to data structure 'sae01'. 05/17/2015 19:35 PM
sae_sent NEW_MAP_ELEMENT Added data element 'sae_sent' to data structure 'sae01'. 05/17/2015 19:35 PM
saes_sent NEW_MAP_ELEMENT Added data element 'saes_sent' to data structure 'sae01'. 05/17/2015 19:35 PM
q1_14e1 NEW_MAP_ELEMENT Added data element 'q1_14e1' to data structure 'sae01'. 05/17/2015 19:35 PM
q1_14f1 NEW_MAP_ELEMENT Added data element 'q1_14f1' to data structure 'sae01'. 05/17/2015 19:35 PM
q1_14g1 NEW_MAP_ELEMENT Added data element 'q1_14g1' to data structure 'sae01'. 05/17/2015 19:35 PM
q1_14h1 NEW_MAP_ELEMENT Added data element 'q1_14h1' to data structure 'sae01'. 05/17/2015 19:35 PM
q1_14i1 NEW_MAP_ELEMENT Added data element 'q1_14i1' to data structure 'sae01'. 05/17/2015 19:35 PM
q1_16a1 NEW_MAP_ELEMENT Added data element 'q1_16a1' to data structure 'sae01'. 05/17/2015 19:35 PM
q1_16b1 NEW_MAP_ELEMENT Added data element 'q1_16b1' to data structure 'sae01'. 05/17/2015 19:35 PM
q1_16c1 NEW_MAP_ELEMENT Added data element 'q1_16c1' to data structure 'sae01'. 05/17/2015 19:35 PM
q1_14a1 NEW_MAP_ELEMENT Added data element 'q1_14a1' to data structure 'sae01'. 05/17/2015 19:35 PM
q1_14b1 NEW_MAP_ELEMENT Added data element 'q1_14b1' to data structure 'sae01'. 05/17/2015 19:35 PM
q1_14c1 NEW_MAP_ELEMENT Added data element 'q1_14c1' to data structure 'sae01'. 05/17/2015 19:35 PM
q1_14d1 NEW_MAP_ELEMENT Added data element 'q1_14d1' to data structure 'sae01'. 05/17/2015 19:35 PM
sae_sent NEW_DATA_ELEMENT 05/17/2015 19:35 PM
saes_sent NEW_DATA_ELEMENT 05/17/2015 19:35 PM
stdate1 NEW_DATA_ELEMENT 05/17/2015 19:15 PM
phase NOTES NOTES: NOTES: 9 =follow up 05/14/2015 18:50 PM
study NEW_MAP_ELEMENT Added data element 'study' to data structure 'sae01'. 04/30/2015 17:28 PM
autpsydt NEW_MAP_ELEMENT Added data element 'autpsydt' to data structure 'sae01'. 04/27/2015 17:37 PM
comments_misc NEW_MAP_ELEMENT Added data element 'comments_misc' to data structure 'sae01'. 04/27/2015 17:37 PM
reason_for_rejection NEW_MAP_ELEMENT Added data element 'reason_for_rejection' to data structure 'sae01'. 04/27/2015 17:37 PM
requestsae NEW_MAP_ELEMENT Added data element 'requestsae' to data structure 'sae01'. 04/27/2015 17:37 PM
sae_sequelae NEW_MAP_ELEMENT Added data element 'sae_sequelae' to data structure 'sae01'. 04/27/2015 17:37 PM
saeothsp NEW_MAP_ELEMENT Added data element 'saeothsp' to data structure 'sae01'. 04/27/2015 17:37 PM
weight_met NEW_MAP_ELEMENT Added data element 'weight_met' to data structure 'sae01'. 04/27/2015 17:37 PM
ae_serious_anomaly NEW_MAP_ELEMENT Added data element 'ae_serious_anomaly' to data structure 'sae01'. 04/27/2015 17:37 PM
ae_serious_death NEW_MAP_ELEMENT Added data element 'ae_serious_death' to data structure 'sae01'. 04/27/2015 17:37 PM
ae_serious_disable NEW_MAP_ELEMENT Added data element 'ae_serious_disable' to data structure 'sae01'. 04/27/2015 17:37 PM
ae_serious_hospital NEW_MAP_ELEMENT Added data element 'ae_serious_hospital' to data structure 'sae01'. 04/27/2015 17:37 PM
ae_serious_signific NEW_MAP_ELEMENT Added data element 'ae_serious_signific' to data structure 'sae01'. 04/27/2015 17:37 PM
ae_serious_threat NEW_MAP_ELEMENT Added data element 'ae_serious_threat' to data structure 'sae01'. 04/27/2015 17:37 PM
aeid NEW_MAP_ELEMENT Added data element 'aeid' to data structure 'sae01'. 04/27/2015 17:37 PM
aeterm NEW_MAP_ELEMENT Added data element 'aeterm' to data structure 'sae01'. 04/27/2015 17:37 PM
description_of_sae NEW_MAP_ELEMENT Added data element 'description_of_sae' to data structure 'sae01'. 04/27/2015 17:37 PM
sae_action_other_txt NEW_MAP_ELEMENT Added data element 'sae_action_other_txt' to data structure 'sae01'. 04/27/2015 17:37 PM
ae_serious_anomaly NEW_DATA_ELEMENT 04/27/2015 17:37 PM
ae_serious_death NEW_DATA_ELEMENT 04/27/2015 17:37 PM
ae_serious_disable NEW_DATA_ELEMENT 04/27/2015 17:37 PM
ae_serious_hospital NEW_DATA_ELEMENT 04/27/2015 17:37 PM
ae_serious_signific NEW_DATA_ELEMENT 04/27/2015 17:37 PM
ae_serious_threat NEW_DATA_ELEMENT 04/27/2015 17:37 PM
description_of_sae NEW_DATA_ELEMENT 04/27/2015 17:37 PM
sae_action_other_txt NEW_DATA_ELEMENT 04/27/2015 17:37 PM
sae_sequelae NEW_DATA_ELEMENT 04/27/2015 17:37 PM
saeothsp NEW_DATA_ELEMENT 04/27/2015 17:37 PM
session_id NEW_MAP_ELEMENT Added data element 'session_id' to data structure 'sae01'. 04/27/2015 17:37 PM
autpsydt NEW_DATA_ELEMENT 04/27/2015 15:37 PM
aeid NEW_DATA_ELEMENT 04/24/2015 17:37 PM
reason_for_rejection NEW_DATA_ELEMENT 04/24/2015 17:37 PM
requestsae NEW_DATA_ELEMENT 04/24/2015 17:37 PM
aeterm NEW_DATA_ELEMENT 04/23/2015 11:31 AM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 04/22/2015 17:28 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 04/22/2015 17:25 PM
saedig ELEMENT_SIZE ELEMENT_SIZE: 150 ELEMENT_SIZE: 200 04/22/2015 17:08 PM
saeexp VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: 0=No; 1=Yes VALUE_RANGE: 0;1; 9 NOTES: 0=No; 1=Yes; 9=unknown 04/22/2015 16:19 PM
abate VALUE_RANGE VALUE_RANGE: 0:2 VALUE_RANGE: 0::2 04/22/2015 15:49 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 04/17/2015 15:02 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 04/17/2015 13:06 PM
saea26a3a NEW_MAP_ELEMENT Added data element 'saea26a3a' to data structure 'sae01'. 04/15/2015 17:31 PM
saea26b3a NEW_MAP_ELEMENT Added data element 'saea26b3a' to data structure 'sae01'. 04/15/2015 17:31 PM
saea26c3 NEW_MAP_ELEMENT Added data element 'saea26c3' to data structure 'sae01'. 04/15/2015 17:31 PM
saea26c3a NEW_MAP_ELEMENT Added data element 'saea26c3a' to data structure 'sae01'. 04/15/2015 17:31 PM
saea26d3 NEW_MAP_ELEMENT Added data element 'saea26d3' to data structure 'sae01'. 04/15/2015 17:31 PM
saea26d3a NEW_MAP_ELEMENT Added data element 'saea26d3a' to data structure 'sae01'. 04/15/2015 17:31 PM
mdga20a NEW_MAP_ELEMENT Added data element 'mdga20a' to data structure 'sae01'. 04/15/2015 17:31 PM
mdga20b NEW_MAP_ELEMENT Added data element 'mdga20b' to data structure 'sae01'. 04/15/2015 17:31 PM
mdga20c NEW_MAP_ELEMENT Added data element 'mdga20c' to data structure 'sae01'. 04/15/2015 17:31 PM
mdga20d NEW_MAP_ELEMENT Added data element 'mdga20d' to data structure 'sae01'. 04/15/2015 17:31 PM
saea26a2 NEW_MAP_ELEMENT Added data element 'saea26a2' to data structure 'sae01'. 04/15/2015 17:31 PM
saea26a3 NEW_MAP_ELEMENT Added data element 'saea26a3' to data structure 'sae01'. 04/15/2015 17:31 PM
saea26b2 NEW_MAP_ELEMENT Added data element 'saea26b2' to data structure 'sae01'. 04/15/2015 17:31 PM
saea26b3 NEW_MAP_ELEMENT Added data element 'saea26b3' to data structure 'sae01'. 04/15/2015 17:31 PM
saea26c2 NEW_MAP_ELEMENT Added data element 'saea26c2' to data structure 'sae01'. 04/15/2015 17:31 PM
saea26d2 NEW_MAP_ELEMENT Added data element 'saea26d2' to data structure 'sae01'. 04/15/2015 17:31 PM
cont12 NEW_MAP_ELEMENT Added data element 'cont12' to data structure 'sae01'. 04/15/2015 17:31 PM
dscript10 NEW_MAP_ELEMENT Added data element 'dscript10' to data structure 'sae01'. 04/15/2015 17:31 PM
dscript11 NEW_MAP_ELEMENT Added data element 'dscript11' to data structure 'sae01'. 04/15/2015 17:31 PM
dscript12 NEW_MAP_ELEMENT Added data element 'dscript12' to data structure 'sae01'. 04/15/2015 17:31 PM
dscript6 NEW_MAP_ELEMENT Added data element 'dscript6' to data structure 'sae01'. 04/15/2015 17:31 PM
dscript7 NEW_MAP_ELEMENT Added data element 'dscript7' to data structure 'sae01'. 04/15/2015 17:31 PM
dscript8 NEW_MAP_ELEMENT Added data element 'dscript8' to data structure 'sae01'. 04/15/2015 17:31 PM
dscript9 NEW_MAP_ELEMENT Added data element 'dscript9' to data structure 'sae01'. 04/15/2015 17:31 PM
med11drz NEW_MAP_ELEMENT Added data element 'med11drz' to data structure 'sae01'. 04/15/2015 17:31 PM
med12drz NEW_MAP_ELEMENT Added data element 'med12drz' to data structure 'sae01'. 04/15/2015 17:31 PM
med12rz NEW_MAP_ELEMENT Added data element 'med12rz' to data structure 'sae01'. 04/15/2015 17:31 PM
cont10 NEW_MAP_ELEMENT Added data element 'cont10' to data structure 'sae01'. 04/15/2015 17:31 PM
cont11 NEW_MAP_ELEMENT Added data element 'cont11' to data structure 'sae01'. 04/15/2015 17:31 PM
cont8 NEW_MAP_ELEMENT Added data element 'cont8' to data structure 'sae01'. 04/15/2015 17:31 PM
cont9 NEW_MAP_ELEMENT Added data element 'cont9' to data structure 'sae01'. 04/15/2015 17:31 PM
med10drz NEW_MAP_ELEMENT Added data element 'med10drz' to data structure 'sae01'. 04/15/2015 17:31 PM
med10rz NEW_MAP_ELEMENT Added data element 'med10rz' to data structure 'sae01'. 04/15/2015 17:31 PM
med11rz NEW_MAP_ELEMENT Added data element 'med11rz' to data structure 'sae01'. 04/15/2015 17:31 PM
med8drz NEW_MAP_ELEMENT Added data element 'med8drz' to data structure 'sae01'. 04/15/2015 17:31 PM
med8rz NEW_MAP_ELEMENT Added data element 'med8rz' to data structure 'sae01'. 04/15/2015 17:31 PM
med9drz NEW_MAP_ELEMENT Added data element 'med9drz' to data structure 'sae01'. 04/15/2015 17:31 PM
med9rz NEW_MAP_ELEMENT Added data element 'med9rz' to data structure 'sae01'. 04/15/2015 17:31 PM
cont5 NEW_MAP_ELEMENT Added data element 'cont5' to data structure 'sae01'. 04/15/2015 17:31 PM
cont6 NEW_MAP_ELEMENT Added data element 'cont6' to data structure 'sae01'. 04/15/2015 17:31 PM
cont7 NEW_MAP_ELEMENT Added data element 'cont7' to data structure 'sae01'. 04/15/2015 17:31 PM
dscript10 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
dscript11 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
dscript12 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
dscript6 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
dscript7 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
dscript8 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
dscript9 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
med5drz NEW_MAP_ELEMENT Added data element 'med5drz' to data structure 'sae01'. 04/15/2015 17:31 PM
med5rz NEW_MAP_ELEMENT Added data element 'med5rz' to data structure 'sae01'. 04/15/2015 17:31 PM
med6drz NEW_MAP_ELEMENT Added data element 'med6drz' to data structure 'sae01'. 04/15/2015 17:31 PM
med6rz NEW_MAP_ELEMENT Added data element 'med6rz' to data structure 'sae01'. 04/15/2015 17:31 PM
med7drz NEW_MAP_ELEMENT Added data element 'med7drz' to data structure 'sae01'. 04/15/2015 17:31 PM
med7rz NEW_MAP_ELEMENT Added data element 'med7rz' to data structure 'sae01'. 04/15/2015 17:31 PM
saea26a2 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
saea26a3 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
saea26a3a NEW_DATA_ELEMENT 04/15/2015 17:31 PM
saea26b2 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
saea26b3 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
saea26b3a NEW_DATA_ELEMENT 04/15/2015 17:31 PM
saea26c2 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
saea26c3 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
saea26c3a NEW_DATA_ELEMENT 04/15/2015 17:31 PM
saea26d2 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
saea26d3 NEW_DATA_ELEMENT 04/15/2015 17:31 PM
saea26d3a NEW_DATA_ELEMENT 04/15/2015 17:31 PM
saedig ELEMENT_SIZE ELEMENT_SIZE: 50 ELEMENT_SIZE: 150 04/15/2015 16:32 PM
abate VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: 0=No; 1= Yes VALUE_RANGE: 0:2 NOTES: 0=No; 1= Yes; 2=NA 04/15/2015 16:29 PM
mdga20a ELEMENT_SIZE ELEMENT_SIZE: 50 ELEMENT_SIZE: 150 04/15/2015 15:38 PM
mdga20b ELEMENT_SIZE ELEMENT_SIZE: 50 ELEMENT_SIZE: 150 04/15/2015 15:38 PM
mdga20c ELEMENT_SIZE ELEMENT_SIZE: 50 ELEMENT_SIZE: 150 04/15/2015 15:38 PM
mdga20d ELEMENT_SIZE ELEMENT_SIZE: 50 ELEMENT_SIZE: 150 04/15/2015 15:38 PM
autopsy VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: 0=No; 1= Yes VALUE_RANGE: 0;1; 999 NOTES: 0 = No; 1 = Yes; 999 = Legitimately Skipped 04/14/2015 18:56 PM
suicide VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: 0=No; 1= Yes VALUE_RANGE: 0;1; 999 NOTES: 0 = No; 1 = Yes; 999 = Legitimately Skipped 04/14/2015 18:56 PM
medication1_name NOTES NOTES: NOTES: Add 999= Legitimately skipped; 04/14/2015 18:52 PM
medication2_name NOTES NOTES: NOTES: Add 999= Legitimately skipped; 04/14/2015 18:52 PM
medication3_name NOTES NOTES: NOTES: Add 999= Legitimately skipped; 04/14/2015 18:52 PM
medication4_name NOTES NOTES: NOTES: Add 999= Legitimately skipped; 04/14/2015 18:52 PM
adl_q04 NEW_DATA_ELEMENT 04/13/2015 11:51 AM
study NOTES NOTES: CPEA or STAART Study NOTES: 04/13/2015 11:31 AM
iphosp NEW_MAP_ELEMENT Added data element 'iphosp' to data structure 'sae01'. 04/10/2015 16:16 PM
sae9dt NEW_MAP_ELEMENT Added data element 'sae9dt' to data structure 'sae01'. 04/10/2015 16:16 PM
sae9vis NEW_MAP_ELEMENT Added data element 'sae9vis' to data structure 'sae01'. 04/10/2015 16:16 PM
iphosp NEW_DATA_ELEMENT 04/10/2015 16:16 PM
sae9dt NEW_DATA_ELEMENT 04/10/2015 16:16 PM
sae9vis NEW_DATA_ELEMENT 04/10/2015 16:16 PM
saea13 NEW_DATA_ELEMENT 04/10/2015 16:16 PM
saea13 NEW_MAP_ELEMENT Added data element 'saea13' to data structure 'sae01'. 04/10/2015 16:16 PM
saea15a NEW_DATA_ELEMENT 04/10/2015 16:16 PM
saea15a NEW_MAP_ELEMENT Added data element 'saea15a' to data structure 'sae01'. 04/10/2015 16:16 PM
saea15b NEW_DATA_ELEMENT 04/10/2015 16:16 PM
saea15b NEW_MAP_ELEMENT Added data element 'saea15b' to data structure 'sae01'. 04/10/2015 16:16 PM
saea5ex NEW_DATA_ELEMENT 04/10/2015 16:16 PM
saea5ex NEW_MAP_ELEMENT Added data element 'saea5ex' to data structure 'sae01'. 04/10/2015 16:16 PM
saea7a NEW_DATA_ELEMENT 04/10/2015 16:16 PM
saea7a NEW_MAP_ELEMENT Added data element 'saea7a' to data structure 'sae01'. 04/10/2015 16:16 PM
mdga20a NEW_DATA_ELEMENT 04/10/2015 15:57 PM
mdga20b NEW_DATA_ELEMENT 04/10/2015 15:57 PM
mdga20c NEW_DATA_ELEMENT 04/10/2015 15:57 PM
mdga20d NEW_DATA_ELEMENT 04/10/2015 15:57 PM
subject_description NEW_MAP_ELEMENT Added data element 'subject_description' to data structure 'sae01'. 04/09/2015 17:11 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 04/07/2015 15:50 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 04/07/2015 15:32 PM
saea10c NEW_DATA_ELEMENT 04/06/2015 17:37 PM
saea10c NEW_MAP_ELEMENT Added data element 'saea10c' to data structure 'sae01'. 04/06/2015 17:37 PM
other REQUIRED REQUIRED: Required REQUIRED: Recommended 04/03/2015 17:38 PM
visday NEW_MAP_ELEMENT Added data element 'visday' to data structure 'sae01'. 04/03/2015 17:29 PM
saea17a VALUE_RANGE VALUE_RANGE: mm/dd/yyyy VALUE_RANGE: 04/03/2015 17:27 PM
saea18a VALUE_RANGE VALUE_RANGE: mm/dd/yyyy VALUE_RANGE: 04/03/2015 17:27 PM
saea19b VALUE_RANGE VALUE_RANGE: mm/dd/yyy VALUE_RANGE: 04/03/2015 17:27 PM
saea3 VALUE_RANGE VALUE_RANGE: mm/dd/yyyy VALUE_RANGE: 04/03/2015 17:27 PM
saea5 VALUE_RANGE VALUE_RANGE: mm/dd/yyyy VALUE_RANGE: 04/03/2015 17:27 PM
saea6 VALUE_RANGE VALUE_RANGE: mm/dd/yyyy VALUE_RANGE: 04/03/2015 17:27 PM
saea4 DESCRIPTION, VALUE_RANGE DESCRIPTION: Age at onset VALUE_RANGE: 0::150 DESCRIPTION: Age at onset, months VALUE_RANGE: 0::1200 04/03/2015 17:25 PM
saea10b1 POSITION POSITION: 269 POSITION: 268 04/02/2015 16:37 PM
saea14 POSITION POSITION: 270 POSITION: 269 04/02/2015 16:37 PM
saea15 POSITION POSITION: 271 POSITION: 270 04/02/2015 16:37 PM
saea16 POSITION POSITION: 272 POSITION: 271 04/02/2015 16:37 PM
saea17 POSITION POSITION: 273 POSITION: 272 04/02/2015 16:37 PM
saea17a POSITION POSITION: 274 POSITION: 273 04/02/2015 16:37 PM
saea18a POSITION POSITION: 275 POSITION: 274 04/02/2015 16:37 PM
saea19 POSITION POSITION: 276 POSITION: 275 04/02/2015 16:37 PM
saea19b POSITION POSITION: 277 POSITION: 276 04/02/2015 16:37 PM
saea3 POSITION POSITION: 265 POSITION: 264 04/02/2015 16:37 PM
saea4 POSITION POSITION: 266 POSITION: 265 04/02/2015 16:37 PM
saea5 POSITION POSITION: 267 POSITION: 266 04/02/2015 16:37 PM
saea6 POSITION POSITION: 268 POSITION: 267 04/02/2015 16:37 PM
version_form POSITION POSITION: 278 POSITION: 277 04/02/2015 16:37 PM
saea15 NEW_MAP_ELEMENT Added data element 'saea15' to data structure 'sae01'. 04/02/2015 15:56 PM
saea16 NEW_MAP_ELEMENT Added data element 'saea16' to data structure 'sae01'. 04/02/2015 15:56 PM
saea17 NEW_MAP_ELEMENT Added data element 'saea17' to data structure 'sae01'. 04/02/2015 15:56 PM
saea17a NEW_MAP_ELEMENT Added data element 'saea17a' to data structure 'sae01'. 04/02/2015 15:56 PM
saea18a NEW_MAP_ELEMENT Added data element 'saea18a' to data structure 'sae01'. 04/02/2015 15:56 PM
saea19 NEW_MAP_ELEMENT Added data element 'saea19' to data structure 'sae01'. 04/02/2015 15:56 PM
saea19b NEW_MAP_ELEMENT Added data element 'saea19b' to data structure 'sae01'. 04/02/2015 15:56 PM
version_form NEW_MAP_ELEMENT Added data element 'version_form' to data structure 'sae01'. 04/02/2015 15:56 PM
fseqno NEW_MAP_ELEMENT Added data element 'fseqno' to data structure 'sae01'. 04/02/2015 15:56 PM
sae0b NEW_DATA_ELEMENT 04/02/2015 15:56 PM
sae0b NEW_MAP_ELEMENT Added data element 'sae0b' to data structure 'sae01'. 04/02/2015 15:56 PM
saea10b1 NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea10b1 NEW_MAP_ELEMENT Added data element 'saea10b1' to data structure 'sae01'. 04/02/2015 15:56 PM
saea14 NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea14 NEW_MAP_ELEMENT Added data element 'saea14' to data structure 'sae01'. 04/02/2015 15:56 PM
saea15 NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea16 NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea17 NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea17a NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea18a NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea19 NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea19b NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea3 NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea3 NEW_MAP_ELEMENT Added data element 'saea3' to data structure 'sae01'. 04/02/2015 15:56 PM
saea4 NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea4 NEW_MAP_ELEMENT Added data element 'saea4' to data structure 'sae01'. 04/02/2015 15:56 PM
saea5 NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea5 NEW_MAP_ELEMENT Added data element 'saea5' to data structure 'sae01'. 04/02/2015 15:56 PM
saea6 NEW_DATA_ELEMENT 04/02/2015 15:56 PM
saea6 NEW_MAP_ELEMENT Added data element 'saea6' to data structure 'sae01'. 04/02/2015 15:56 PM
visitid NEW_MAP_ELEMENT Added data element 'visitid' to data structure 'sae01'. 04/02/2015 15:56 PM
lab020 NEW_DATA_ELEMENT 04/01/2015 17:02 PM
fseqno NEW_DATA_ELEMENT 04/01/2015 12:43 PM
medication1_route NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication2_route NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication2_start NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication3_route NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication3_start NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication3_stop NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication4_route NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication4_stop NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication5_route NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication5_start NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication5_stop NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication6_start NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication6_stop NEW_DATA_ELEMENT 03/26/2015 16:37 PM
medication4_start NEW_DATA_ELEMENT 03/26/2015 16:37 PM
study_drug_team NEW_DATA_ELEMENT 03/24/2015 10:11 AM
other REQUIRED REQUIRED: Recommended REQUIRED: Required 03/09/2015 08:01 AM
other VALUE_RANGE VALUE_RANGE: 0;1 VALUE_RANGE: 0;1;999 03/09/2015 07:27 AM
medication10_day NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication10_dose NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication1_day NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication1_dose NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication2_day NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication2_dose NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication3_day NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication3_dose NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication4_day NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication4_dose NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication5_day NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication5_dose NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication6_day NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication6_dose NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication7_day NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication7_dose NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication8_day NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication8_dose NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication9_day NEW_DATA_ELEMENT 02/27/2015 15:02 PM
medication9_dose NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_10 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_12 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_13 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_14 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_15 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_16 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_17 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_18 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_19 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_20 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_21 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_36 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_37 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_38 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_39 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_40 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_41 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_42 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_86 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_87 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_88 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_date_entered NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_reported_date_sc NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_reported_time_sc NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_reported_to_date NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_reported_to_time NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_time_entered NEW_DATA_ELEMENT 02/27/2015 15:02 PM
sae_time_incident NEW_DATA_ELEMENT 02/27/2015 15:02 PM
saes_01 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
saes_02 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
saes_04 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
saes_06 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
saes_07 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
saes_08 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
saes_11 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
saes_15 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
saes_16 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
saes_17 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
saes_18 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
saes_19 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
exprrz DESCRIPTION DESCRIPTION: expernce onset days since rz DESCRIPTION: experience onset days since randomization 02/27/2015 14:40 PM
session_id DESCRIPTION DESCRIPTION: session ID DESCRIPTION: session ID/screening ID 02/24/2015 11:04 AM
hi_31c6 NEW_DATA_ELEMENT 01/22/2015 13:33 PM
hi_31d6 NEW_DATA_ELEMENT 01/22/2015 13:33 PM
hi_31e6 NEW_DATA_ELEMENT 01/22/2015 13:33 PM
hi_31a6 NEW_DATA_ELEMENT 01/22/2015 13:33 PM
hi_31b6 NEW_DATA_ELEMENT 01/22/2015 13:33 PM
hi_31b5 NEW_DATA_ELEMENT 01/22/2015 13:33 PM
hi_31a5 NEW_DATA_ELEMENT 01/22/2015 13:33 PM
hi_31d5 NEW_DATA_ELEMENT 01/22/2015 13:33 PM
hi_31c5 NEW_DATA_ELEMENT 01/22/2015 13:33 PM
hi_31e5 NEW_DATA_ELEMENT 01/22/2015 13:33 PM
phase_ct DESCRIPTION DESCRIPTION: Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. DESCRIPTION: Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. 01/13/2015 17:38 PM
src_subject_id DESCRIPTION DESCRIPTION: The site or study's subject identification DESCRIPTION: Subject ID how it's defined in lab/project 01/12/2015 18:22 PM
ca17 NEW_DATA_ELEMENT 01/08/2015 16:04 PM
version_form NEW_DATA_ELEMENT 01/05/2015 16:36 PM
week DESCRIPTION DESCRIPTION: Week in level DESCRIPTION: Week in level/study 01/05/2015 11:19 AM
ptdose NEW_DATA_ELEMENT 01/02/2015 16:47 PM
sae_code VALUE_RANGE, NOTES VALUE_RANGE: DS;DN;T;MH;MI;PS;PHS;PHW;PHA;PHO;PHI;PHT;PSI;PST;MP;PHX;PHM;PHSI;PHSA NOTES: DS=Death-suicide; DN=Death-non suicide; T=Suspected serious side effect of medication treatment; MH=Medical event-hospitalization; MI=Medical event-illness/symptom/diagnosis not requiring hospitalization; PS=Psychiatric event-suicidal ideation (non hospitalized); PHS=Psychiatric event-hospitalization/suicide attempt or ideation; PHW=Psychiatric event-hospitalization/worsening depression; PHA=Psychiatric event-hospitalization/substance abuse detoxification; PHO=Psychiatric event-hospitalization/psychiatric event other than above; PHI=Psychiatric event-hospitalization/illness; PHT=Psychiatric event-hospitalization/side effect of med treatment; PSI=Psychiatric event-suicidal ideation/illness; PST=Psychiatric event-suicidal ideation/side effect of med treatment; MP=Medical Procedure (e.g., delivery of baby); PHX=Psychiatric event-hospitalization involving increase of mixed symptoms; PHM=Psychiatric event-hospitalization involving increase of manic or hypomanic symptoms; PHSI=Psychiatric event-hospitalization involving suicidal ideation; PHSA=Psychiatric event-hospitalization involving suicidal attempt VALUE_RANGE: DS;DN;T;MH;MI;PS;PHS;PHW;PHA;PHO;PHI;PHT;PSI;PST;MP;PHX;PHM;PHSI;PHSA;PHD;PSA;PO NOTES: DS=Death-suicide; DN=Death-non suicide; T=Suspected serious side effect of medication treatment; MH=Medical event-hospitalization; MI=Medical event-illness/symptom/diagnosis not requiring hospitalization; PS=Psychiatric event-suicidal ideation (non hospitalized); PHS=Psychiatric event-hospitalization/suicide attempt or ideation; PHW=Psychiatric event-hospitalization/worsening depression; PHA=Psychiatric event-hospitalization/substance abuse detoxification; PHO=Psychiatric event-hospitalization/psychiatric event other than above; PHI=Psychiatric event-hospitalization/illness; PHT=Psychiatric event-hospitalization/side effect of med treatment; PSI=Psychiatric event-suicidal ideation/illness; PST=Psychiatric event-suicidal ideation/side effect of med treatment; MP=Medical Procedure (e.g., delivery of baby); PHX=Psychiatric event-hospitalization involving increase of mixed symptoms; PHM=Psychiatric event-hospitalization involving increase of manic or hypomanic symptoms; PHSI=Psychiatric event-hospitalization involving suicidal ideation; PHSA=Psychiatric event-hospitalization involving suicidal attempt; PHD=Psychiatric event-hospitalization involving increase of depressive symptoms; PSA=Psychiatric event-suicide attempt; PO=Psychiatric-event Other 12/31/2014 16:25 PM
sae_code VALUE_RANGE, NOTES VALUE_RANGE: DS;DN;T;MH;MI;PS;PHS;PHW;PHA;PHO;PHI;PHT;PSI;PST NOTES: DS=Death-suicide; DN=Death-non suicide; T=Suspected serious side effect of medication treatment; MH=Medical event-hospitalization; MI=Medical event-illness/symptom/diagnosis not requiring hospitalization; PS=Psychiatric event-suicidal ideation (non hospitalized); PHS=Psychiatric event-hospitalization/suicide attempt or ideation; PHW=Psychiatric event-hospitalization/worsening depression; PHA=Psychiatric event-hospitalization/substance abuse detoxification; PHO=Psychiatric event-hospitalization/psychiatric event other than above; PHI=Psychiatric event-hospitalization/illness; PHT=Psychiatric event-hospitalization/side effect of med treatment; PSI=Psychiatric event-suicidal ideation/illness; PST=Psychiatric event-suicidal ideation/side effect of med treatment VALUE_RANGE: DS;DN;T;MH;MI;PS;PHS;PHW;PHA;PHO;PHI;PHT;PSI;PST;MP;PHX;PHM;PHSI;PHSA NOTES: DS=Death-suicide; DN=Death-non suicide; T=Suspected serious side effect of medication treatment; MH=Medical event-hospitalization; MI=Medical event-illness/symptom/diagnosis not requiring hospitalization; PS=Psychiatric event-suicidal ideation (non hospitalized); PHS=Psychiatric event-hospitalization/suicide attempt or ideation; PHW=Psychiatric event-hospitalization/worsening depression; PHA=Psychiatric event-hospitalization/substance abuse detoxification; PHO=Psychiatric event-hospitalization/psychiatric event other than above; PHI=Psychiatric event-hospitalization/illness; PHT=Psychiatric event-hospitalization/side effect of med treatment; PSI=Psychiatric event-suicidal ideation/illness; PST=Psychiatric event-suicidal ideation/side effect of med treatment; MP=Medical Procedure (e.g., delivery of baby); PHX=Psychiatric event-hospitalization involving increase of mixed symptoms; PHM=Psychiatric event-hospitalization involving increase of manic or hypomanic symptoms; PHSI=Psychiatric event-hospitalization involving suicidal ideation; PHSA=Psychiatric event-hospitalization involving suicidal attempt 12/30/2014 15:40 PM
cont10 NEW_DATA_ELEMENT 12/26/2014 12:43 PM
cont11 NEW_DATA_ELEMENT 12/26/2014 12:43 PM
cont12 NEW_DATA_ELEMENT 12/26/2014 12:43 PM
cont5 NEW_DATA_ELEMENT 12/26/2014 12:43 PM
cont6 NEW_DATA_ELEMENT 12/26/2014 12:43 PM
cont7 NEW_DATA_ELEMENT 12/26/2014 12:43 PM
cont8 NEW_DATA_ELEMENT 12/26/2014 12:43 PM
cont9 NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med10drz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med10rz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med11drz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med11rz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med12drz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med12rz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med5drz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med5rz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med6drz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med6rz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med7drz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med7rz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med8drz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med8rz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med9drz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
med9rz NEW_DATA_ELEMENT 12/26/2014 12:43 PM
route5 NEW_DATA_ELEMENT 12/26/2014 12:43 PM
route6 NEW_DATA_ELEMENT 12/26/2014 12:43 PM
exprrz NEW_DATA_ELEMENT 12/26/2014 11:49 AM
rcpenrl NEW_DATA_ELEMENT 12/26/2014 11:49 AM
rcpptway NEW_DATA_ELEMENT 12/26/2014 11:49 AM
rslvrz NEW_DATA_ELEMENT 12/26/2014 11:49 AM
dscript1 NEW_DATA_ELEMENT 12/11/2014 17:42 PM
dscript2 NEW_DATA_ELEMENT 12/11/2014 17:42 PM
dscript3 NEW_DATA_ELEMENT 12/11/2014 17:42 PM
dscript4 NEW_DATA_ELEMENT 12/11/2014 17:42 PM
dscript5 NEW_DATA_ELEMENT 12/11/2014 17:42 PM
flwup1 NEW_DATA_ELEMENT 12/11/2014 17:42 PM
flwup2 NEW_DATA_ELEMENT 12/11/2014 17:42 PM
medmon NEW_DATA_ELEMENT 12/11/2014 17:42 PM
nochange NEW_DATA_ELEMENT 12/11/2014 17:42 PM
sae_code NEW_DATA_ELEMENT 12/11/2014 17:42 PM
saeexp NEW_DATA_ELEMENT 12/11/2014 17:42 PM
saenumber NEW_DATA_ELEMENT 12/11/2014 17:42 PM
saerel NEW_DATA_ELEMENT 12/11/2014 17:42 PM
saetrue NEW_DATA_ELEMENT 12/11/2014 17:42 PM
mtype NEW_DATA_ELEMENT 12/10/2014 14:32 PM
crcid DESCRIPTION DESCRIPTION: CRC ID DESCRIPTION: CRC ID/ROA ID 12/09/2014 16:17 PM
therdura TYPE, ELEMENT_SIZE TYPE: Integer ELEMENT_SIZE: TYPE: String ELEMENT_SIZE: 50 12/02/2014 13:36 PM
gender VALUE_RANGE, NOTES VALUE_RANGE: M;F NOTES: M = Male; F = Female VALUE_RANGE: M;F; T NOTES: M = Male; F = Female; T= Transgender 12/01/2014 12:34 PM
medcur1 NEW_DATA_ELEMENT 12/01/2014 11:11 AM
medcur2 NEW_DATA_ELEMENT 12/01/2014 11:11 AM
medcur3 NEW_DATA_ELEMENT 12/01/2014 11:11 AM
medcur4 NEW_DATA_ELEMENT 12/01/2014 11:11 AM
route VALUE_RANGE, NOTES VALUE_RANGE: NOTES: 1=Oral VALUE_RANGE: 1::5 NOTES: 1=Oral; 2=Nassal; 3=Smoking; 4=Non IV injection; 5=IV injection 12/01/2014 10:24 AM
Data Structure Change History

This page displays a list of all the changes that have been made to this data structure since its original definition. You can view the element name, the attribute that was changed, previous and subsequent values, and the timestamp of the change. Use the search bar to filter the displayed changes.

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